Job Description
Product Development Project Manager
Medical Devices | Biomaterials | Wound Care
Cardiff, UK (on‑site minimum 3 days per week)
We are partnering with a high‑science biomaterials company at a critical point in its product journey. The business is ISO‑certified, operates in a regulated medical device environment, and is progressing a wound‑care device portfolio toward key regulatory milestones.
This is a delivery‑focused product development role. It is not a research position and not a PMO‑only coordination role.
The Role
You will take ownership of the end‑to‑end delivery of a regulated medical device development programme, working from late‑stage development through verification & validation, manufacturing readiness, and regulatory submission support.
Operating within a small, highly technical team, you will act as the link between science, quality, manufacturing, and external partners, ensuring work is delivered to the required standard, on time, and with clear accountability.
There are no large teams to delegate to. This role suits someone who is comfortable rolling up their sleeves, identifying gaps, and taking responsibility for getting things done.
What You’ll Be Responsible For
* Owning and driving product development delivery in a regulated medical device environment
* Working within established quality systems and design control processes
* Coordinating cross‑functional activity across R&D, Quality, Operations, and Manufacturing
* Managing and interfacing with external partners (e.g. CDMOs, CROs, test labs, suppliers)
* Supporting verification & validation activities and ensuring documentation is submission‑ready
* Maintaining momentum against agreed development and regulatory milestones
* Communicating clearly with senior technical and operational stakeholders
What We’re Looking For
The ideal candidate will:
* Have hands‑on experience delivering medical device product development in a regulated environment
* Be comfortable working within quality systems and producing or owning technical documentation
* Have exposure to FDA‑regulated device development (direct submission ownership is not required)
* Be confident coordinating work across multiple disciplines and external partners
* Be happy operating in a lean, non‑hierarchical team, without heavy support structures
* Be able to work on‑site in Cardiff at least 3 days per week
We are flexible on number of years’ experience and seniority, provided you can demonstrate real delivery ownership and judgement in a regulated environment.
Nice to Have
* Experience in wound care, dermal, skin, or biomaterials‑based medical devices
* Exposure to FDA 510(k) submissions (supporting or contributory roles are fine)
* Experience bridging development through to manufacturing scale‑up or tech transfer
* Background in biomaterials, biomedical engineering, materials science, or related fields
* Experience working in a start‑up or scale‑up medical device or biotech environment
Working Style & Environment
* On‑site, collaborative, adult culture focused on outcomes rather than presenteeism
* High level of autonomy and trust
* Opportunity to work on transformational technology, not incremental product updates
* Visible role with real influence on product outcomes
Why This Role
* Directly shape how a novel collagen platform becomes a real‑world wound‑care portfolio.
* Join at a genuine inflection point: late‑stage lead product, capital coming in, clear mandate to build two more devices within a defined timeframe.
* Operate with genuine ownership: your decisions on design, partners and plans will materially affect time‑to‑FDA, scale‑up, and valuation.